MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS MODULAR REVISION HIP SYSTEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ref 11-301351 lot 590330 arcos cone body size a 80mm, ref 163672 lot 403880 cocr head +9mm, ref 01.00013.508 lot 2979280 durasul liner.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -05141.
Event or Problem Description
It was reported initial left total hip arthroplasty performed on an unknown date.The patient underwent her first revision due to periproprosthetic fracture.Subsequently, the patient underwent a second revision approximately one month post revision due to dislocation with femoral subsidence.During the revision procedure, the previous femoral fracture was re-reduced with plate and screws, and the head, liner, and stem were replaced.Attempts have been made and additional information on the reported event is unavailable.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Previous revision op notes demonstrated that the patient was revised due to periprosthetic fracture.Greater trochanter comminuted, short external rotators detached.Abductors unstable with greater trochanter.Prophylactic cable applied to femur distal to fracture.Stem, head, liner removed without complication.Shell stable and left intact.Inserted as one unit as short femur and stem tendency to migrate posteriorly due to femoral bow.Trochanteric fracture stabilized with 6 additional cables.Revision op notes for second revision were not provided.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The short femur and femoral bow may have contributed to the stem subsidence.However, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARCOS MODULAR REVISION HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9321315
• Report Number: 0001825034-2019-05142
• Device Sequence Number: 16240130
• Product Code: KWA
• UDI-Device Identifier: 00880304480612
• UDI-Public: (01)00880304480612
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300913
• Device Lot Number: 742030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 68